Trial Outcomes & Findings for Sex Differences in Risk for Alcohol Abuse (NCT NCT04543942)

NCT ID: NCT04543942

Last Updated: 2024-09-04

Results Overview

Brain activation during response inhibition (BARI) was assessed using blood oxygenation level dependent (BOLD) fMRI during performance of the stop signal task during alcohol (60mg%) infusion. Values were determined by the contrast of BOLD activation during successful inhibition trials relative to go trials.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 28 participants
• Primary outcome timeframe: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together
• Results posted on: 2024-09-04

Participant Flow

Participant milestones

Measure	Alcohol, Then Saline, Then Alcohol, Then Saline Participants first received alcohol (60mg%) intravenously and then 24-48 hours later they received saline intravenously. Two weeks later, they again received alcohol (60mg%) intravenously and then 24 - 48 hours later they received saline intravenously.	Saline, Then Alcohol, Then Saline, Then Alcohol Participants first received saline intravenously and then 24-48 hours later they received alcohol (60mg%) intravenously. Two weeks later, they again received saline intravenously and then 24 - 48 hours later they received alcohol (60mg%) intravenously.
First Intervention (2-3 Days) STARTED	13	15
First Intervention (2-3 Days) COMPLETED	11	13
First Intervention (2-3 Days) NOT COMPLETED	2	2
Interval Period (2 Weeks) STARTED	11	13
Interval Period (2 Weeks) COMPLETED	10	12
Interval Period (2 Weeks) NOT COMPLETED	1	1
Second Intervention (2-3 Days) STARTED	10	12
Second Intervention (2-3 Days) COMPLETED	10	12
Second Intervention (2-3 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Measure	Alcohol, Then Saline, Then Alcohol, Then Saline Participants first received alcohol (60mg%) intravenously and then 24-48 hours later they received saline intravenously. Two weeks later, they again received alcohol (60mg%) intravenously and then 24 - 48 hours later they received saline intravenously.	Saline, Then Alcohol, Then Saline, Then Alcohol Participants first received saline intravenously and then 24-48 hours later they received alcohol (60mg%) intravenously. Two weeks later, they again received saline intravenously and then 24 - 48 hours later they received alcohol (60mg%) intravenously.
First Intervention (2-3 Days) Scheduling conflict	2	2
Interval Period (2 Weeks) scheduling conflict	1	1

Baseline Characteristics

Sex Differences in Risk for Alcohol Abuse

Baseline characteristics by cohort

Measure	Alcohol, Then Saline, Then Alcohol, Then Saline n=13 Participants Participants first received alcohol (60mg%) intravenously and then 24-48 hours later they received saline intravenously. Two weeks later, they again received alcohol (60mg%) intravenously and then 24 - 48 hours later they received saline intravenously.	Saline, Then Alcohol, Then Saline, Then Alcohol n=15 Participants Participants first received saline intravenously and then 24-48 hours later they received alcohol (60mg%) intravenously. Two weeks later, they again received saline intravenously and then 24 - 48 hours later they received alcohol (60mg%) intravenously.	Total n=28 Participants Total of all reporting groups
Age, Continuous	23.7 years STANDARD_DEVIATION 1.8 • n=5 Participants	23.1 years STANDARD_DEVIATION 2.3 • n=7 Participants	23.4 years STANDARD_DEVIATION 2.1 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	15 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together

Brain activation during response inhibition (BARI) was assessed using blood oxygenation level dependent (BOLD) fMRI during performance of the stop signal task during alcohol (60mg%) infusion. Values were determined by the contrast of BOLD activation during successful inhibition trials relative to go trials.

Outcome measures

Measure	Males n=9 Participants Males who received alcohol infusion (60mg%) in either day 1 and 15 or day 2 and 16 of the study.	Females n=13 Participants Females who received alcohol infusion (60mg%) on either day 1 and 15 or day 2 and 16 of the study.
Brain Activation During Response Inhibition (BARI) - Alcohol Infusion	1.83 BOLD activation Standard Deviation 1.11	2.41 BOLD activation Standard Deviation 1.35

PRIMARY outcome

Timeframe: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together

Brain activation during response inhibition (BARI) was assessed using blood oxygenation level dependent (BOLD) fMRI during performance of the stop signal task during saline infusion. Values were determined by the contrast of BOLD activation during successful inhibition trials relative to go trials.

Outcome measures

Measure	Males n=9 Participants Males who received alcohol infusion (60mg%) in either day 1 and 15 or day 2 and 16 of the study.	Females n=13 Participants Females who received alcohol infusion (60mg%) on either day 1 and 15 or day 2 and 16 of the study.
Brain Activation During Response Inhibition (BARI) - Saline Infusion	1.32 BOLD activation Standard Deviation 1.44	2.64 BOLD activation Standard Deviation 1.90

SECONDARY outcome

Timeframe: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together

Estradiol levels (pg/mL) were measured from blood samples following alcohol infusion.

Outcome measures

Measure	Males n=9 Participants Males who received alcohol infusion (60mg%) in either day 1 and 15 or day 2 and 16 of the study.	Females n=13 Participants Females who received alcohol infusion (60mg%) on either day 1 and 15 or day 2 and 16 of the study.
Estradiol Levels - Alcohol Infusion	21.5 pg/mL Standard Deviation 3.2	71.3 pg/mL Standard Deviation 28.8

SECONDARY outcome

Timeframe: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together

Estradiol levels (pg/mL) were measured from blood samples following saline infusion.

Outcome measures

Measure	Males n=9 Participants Males who received alcohol infusion (60mg%) in either day 1 and 15 or day 2 and 16 of the study.	Females n=13 Participants Females who received alcohol infusion (60mg%) on either day 1 and 15 or day 2 and 16 of the study.
Estradiol Levels - Saline Infusion	23.5 pg/mL Standard Deviation 7.0	63.3 pg/mL Standard Deviation 34.0

SECONDARY outcome

Timeframe: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together

Progesterone levels (ng/mL) were measured from blood samples prior to alcohol infusion.

Outcome measures

Measure	Males n=9 Participants Males who received alcohol infusion (60mg%) in either day 1 and 15 or day 2 and 16 of the study.	Females n=13 Participants Females who received alcohol infusion (60mg%) on either day 1 and 15 or day 2 and 16 of the study.
Progesterone Levels - Alcohol Infusion	0.28 ng/mL Standard Deviation 0.07	4.1 ng/mL Standard Deviation 1.7

SECONDARY outcome

Timeframe: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together

Progesterone levels (ng/mL) were measured from blood samples following saline infusion.

Outcome measures

Measure	Males n=9 Participants Males who received alcohol infusion (60mg%) in either day 1 and 15 or day 2 and 16 of the study.	Females n=13 Participants Females who received alcohol infusion (60mg%) on either day 1 and 15 or day 2 and 16 of the study.
Progesterone Levels - Saline Infusion	0.29 ng/mL Standard Deviation 0.09	3.81 ng/mL Standard Deviation 1.95

SECONDARY outcome

Timeframe: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together

Testosterone levels (ng/dL) were measured from blood samples following alcohol infusion.

Outcome measures

Measure	Males n=9 Participants Males who received alcohol infusion (60mg%) in either day 1 and 15 or day 2 and 16 of the study.	Females n=13 Participants Females who received alcohol infusion (60mg%) on either day 1 and 15 or day 2 and 16 of the study.
Testosterone Levels - Alcohol Infusion	544.7 ng/dL Standard Deviation 252.8	39.0 ng/dL Standard Deviation 22.8

SECONDARY outcome

Timeframe: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together

Testosterone levels (ng/dL) were measured from blood samples following saline infusion.

Outcome measures

Measure	Males n=9 Participants Males who received alcohol infusion (60mg%) in either day 1 and 15 or day 2 and 16 of the study.	Females n=13 Participants Females who received alcohol infusion (60mg%) on either day 1 and 15 or day 2 and 16 of the study.
Testosterone Levels - Saline Infusion	454.61 ng/dL Standard Deviation 161.04	23.7 ng/dL Standard Deviation 6.73

SECONDARY outcome

Timeframe: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together

The Biphasic Alcohol Effects Scale (BAES) is a 14-point self-reporting, unipolar adjective rating scale designed to measure both stimulant and sedative effects of alcohol. Scores range from 0-10 for each of the 7 Stimulation sub-scale questions, for a total Stimulation score range of 0-70. Higher scores indicate increased stimulation. This outcome measure was collected during alcohol (60mg%) infusion.

Outcome measures

Measure	Males n=9 Participants Males who received alcohol infusion (60mg%) in either day 1 and 15 or day 2 and 16 of the study.	Females n=13 Participants Females who received alcohol infusion (60mg%) on either day 1 and 15 or day 2 and 16 of the study.
Biphasic Alcohol Effects Score - Stimulation - Alcohol Infusion	32.2 score on a scale Standard Deviation 11.5	23.8 score on a scale Standard Deviation 13.3

SECONDARY outcome

Timeframe: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together

The Biphasic Alcohol Effects Scale (BAES) is a 14-point self-reporting, unipolar adjective rating scale designed to measure both stimulant and sedative effects of alcohol. Scores range from 0-10 for each of the 7 Sedation sub-scale questions, for a total Sedation score range of 0-70. Higher scores indicate increased sedation. This outcome measure was collected during alcohol (60mg%) infusion.

Outcome measures

Measure	Males n=9 Participants Males who received alcohol infusion (60mg%) in either day 1 and 15 or day 2 and 16 of the study.	Females n=13 Participants Females who received alcohol infusion (60mg%) on either day 1 and 15 or day 2 and 16 of the study.
Biphasic Alcohol Effects Score - Sedation - Alcohol Infusion	13.8 score on a scale Standard Deviation 4.7	16.3 score on a scale Standard Deviation 15.3

SECONDARY outcome

Timeframe: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together

The Biphasic Alcohol Effects Scale (BAES) is a 14-point self-reporting, unipolar adjective rating scale designed to measure both stimulant and sedative effects of alcohol. Scores range from 0-10 for each of the 7 Stimulation sub-scale questions, for a total Stimulation score range of 0-70. Higher scores indicate increased stimulation. This outcome measure was collected during saline infusion.

Outcome measures

Measure	Males n=9 Participants Males who received alcohol infusion (60mg%) in either day 1 and 15 or day 2 and 16 of the study.	Females n=13 Participants Females who received alcohol infusion (60mg%) on either day 1 and 15 or day 2 and 16 of the study.
Biphasic Alcohol Effects Scale (BAES) - Stimulation - Saline Infusion	25.1 score on a scale Standard Deviation 13.1	16.9 score on a scale Standard Deviation 11.3

SECONDARY outcome

Timeframe: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together

The Biphasic Alcohol Effects Scale (BAES) is a 14-point self-reporting, unipolar adjective rating scale designed to measure both stimulant and sedative effects of alcohol. Scores range from 0-10 for each of the 7 Sedation sub-scale questions, for a total Sedation score range of 0-70. Higher scores indicate increased stimulation. This outcome measure was collected during saline infusion.

Outcome measures

Measure	Males n=9 Participants Males who received alcohol infusion (60mg%) in either day 1 and 15 or day 2 and 16 of the study.	Females n=13 Participants Females who received alcohol infusion (60mg%) on either day 1 and 15 or day 2 and 16 of the study.
Biphasic Alcohol Effects Scale (BAES) - Sedation - Saline	7.7 score on a scale Standard Deviation 9.5	8.9 score on a scale Standard Deviation 10.1

SECONDARY outcome

Timeframe: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together

The Drug Effects Questionnaire (DEQ) consists of four questions to assess acute subjective response to alcohol intake. This measure captures the amount someone feels the effects of alcohol, on a scale from 0 to 100. Higher scores indicate greater levels of 'feel alcohol'. Scores were obtained during alcohol (60mg%) infusion.

Outcome measures

Measure	Males n=9 Participants Males who received alcohol infusion (60mg%) in either day 1 and 15 or day 2 and 16 of the study.	Females n=13 Participants Females who received alcohol infusion (60mg%) on either day 1 and 15 or day 2 and 16 of the study.
Drug Effects Questionnaire Score - Feel - Alcohol Infusion	73.4 Score on a scale Standard Deviation 7.6	61.7 Score on a scale Standard Deviation 19.5

SECONDARY outcome

Timeframe: During two alcohol sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two alcohol sessions are averaged together

The Drug Effects Questionnaire (DEQ) consists of four questions to assess acute subjective response to alcohol intake. This measure captures the amount someone likes the effects of alcohol, on a scale from 0 to 100. Higher scores indicate greater levels of 'like alcohol'. Scores were obtained during alcohol (60mg%) infusion.

Outcome measures

Measure	Males n=9 Participants Males who received alcohol infusion (60mg%) in either day 1 and 15 or day 2 and 16 of the study.	Females n=13 Participants Females who received alcohol infusion (60mg%) on either day 1 and 15 or day 2 and 16 of the study.
Drug Effects Questionnaire Score - Like - Alcohol Infusion	83.4 Score on a scale Standard Deviation 12.5	65.4 Score on a scale Standard Deviation 17.0

SECONDARY outcome

Timeframe: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together

The Drug Effects Questionnaire (DEQ) consists of four questions to assess acute subjective response to alcohol intake. This measure captures the amount someone feels the effects of alcohol, on a scale from 0 to 100. Higher scores indicate greater levels of 'feel alcohol'. Scores were obtained during saline infusion.

Outcome measures

Measure	Males n=9 Participants Males who received alcohol infusion (60mg%) in either day 1 and 15 or day 2 and 16 of the study.	Females n=13 Participants Females who received alcohol infusion (60mg%) on either day 1 and 15 or day 2 and 16 of the study.
Drug Effects Questionnaire (DEQ) - Feel - Saline Infusion	11.8 score on a scale Standard Deviation 15.3	8.3 score on a scale Standard Deviation 14.2

SECONDARY outcome

Timeframe: During two saline (placebo) sessions which could occur on two of four possible days: 1 or 2 and 15 or 16; data from the two saline sessions are averaged together

The Drug Effects Questionnaire (DEQ) consists of four questions to assess acute subjective response to alcohol intake. This measure captures the amount someone likes the effects of alcohol, on a scale from 0 to 100. Higher scores indicate greater levels of 'like alcohol'. Scores were obtained during saline infusion.

Outcome measures

Measure	Males n=9 Participants Males who received alcohol infusion (60mg%) in either day 1 and 15 or day 2 and 16 of the study.	Females n=13 Participants Females who received alcohol infusion (60mg%) on either day 1 and 15 or day 2 and 16 of the study.
Drug Effects Questionnaire (DEQ) - Like - Saline Infusion	50.5 score on a scale Standard Deviation 7.4	48.8 score on a scale Standard Deviation 2.9

Adverse Events

Males

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Females

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jessica Weafer

The Ohio State University

Phone: 859-533-9878

Email: jessica.weafer@osumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place